FDA 510(k)

SeaSpine WaveForm C 椎间系统

K号: K212904 · 2021-12-14

决定日期2021-12-14

产品代码OVE

咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。

决定实质等同

器械摘要

SeaSpine WaveForm C Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K212904. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SeaSpine WaveForm C Interbody System?

SeaSpine WaveForm C Interbody System is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K212904.

When did SeaSpine WaveForm C Interbody System receive FDA 510(k) clearance?

SeaSpine WaveForm C Interbody System received FDA 510(k) clearance on 2021-12-14, under 510(k) number K212904.

Who is the listed applicant for SeaSpine WaveForm C Interbody System?

The FDA 510(k) record lists SeaSpine Orthopedics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SeaSpine WaveForm C Interbody System?

The FDA product code for SeaSpine WaveForm C Interbody System is OVE.

列明SeaSpine Orthopedics Corporation为申报人的其他记录

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